The overarching goal of the Biostatistics Shared Resource is to establish and maintain the highest possible standards of statistical and scientific quality in the cancer research conducted by the NCCC Programs. The resource provides expert statistical consultation and analysis for all NCCC members;study design, statistical review and interim monitoring for clinical trial protocols;statistical design and expert collaboration for large scale cancer control and epidemiology studies;experimental design and specialized statistical methods for integrative biology and laboratory-based research;statistical data management expertise;and specialized statistical software support and hardware access. The resource is staffed by seven faculty statisticians and three statistical/data management/programmer analysts. Areas of faculty statistical expertise and research include longitudinal data analysis and study design, measurement error methods in clinical research and epidemiology, statistical methods for clinical trials and epidemiology studies, statistical methods for high dimensional genomic and imaging data, clinical decision modeling, cost-effectiveness analysis, and diagnostic test assessment. The BSR faculty provides statistical expertise to the NCCC Clinical Cancer Research and Safety and Data Monitoring Committees for approving and monitoring clinical protocols. The Director of the BSR serves as a member of the Cancer Research Committee and meets weekly with the other NCCC core leaders. The BSR faculty members are active collaborators on numerous NCI-funded projects throughout NCCC and participate in all regularly scheduled Program meetings. Information technology and data management activities at NCCC are managed in coordination with the BSR, NCCC Administration, the Office of Clinical Research, and the Bioinformatics Shared Resource. The BSR data management specialist serves as the NCCC Director of Clinical Information Systems, and provides technical leadership for the ongoing development of clinical research data systems. New initiatives planned for this grant period include the further development of statistical educational seminars and workshops, for researchers at all levels within NCCC, and development of interactive statistical reporting based on the new clinical information system to provide real-time clinical trial safety and data monitoring and access to research data.